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Ex-FDAer Waxler to Oppose Avedro NDA at Advisory Cte.

By Jim Dickinson

02/18/2015

Former CDRH ophthalmic devices branch chief Morris Waxler will next week oppose an Avedro Inc. NDA seeking approval for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery. The venue: the 2/24 joint meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee.

The basic issue in Waxler’s opposition is the failure of the applicant to demonstrate long-term product safety in a prior LASIK PMA application as Summit Technology in 1995, which Waxler approved as branch chief.

In a presentation to be delivered in his absence, Waxler says the NDA presents “at least two public health dilemmas” for the committees because the product masks “a high rate of LASIK-induced ectasia” when the true rate is unknown, and “how many legally blind people are acceptable to you for a few years of ’20-happy vision?'”

Waxler’s presentation says that FDA’s “collaboration with the refractive surgery industry has created a LASIK-induced epidemic of sick corneas…. The true rate of LASIK-induced ectasia will be buried forever if the panel recommends approval of FDA’s plans to approve products polymerizing sick corneas.”

Waxler, who unsuccessfully petitioned against his own approval of the LASIK indication for excimer lasers because of alleged data falsification he found later, says FDA leadership on LASIK products “has a long-standing collegial and professional bias towards ophthalmic professionals in the industry. They work out many issues in regular private meetings; I know because I led many of these meetings and know of many others.”